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FDA Approves Cemiplimab for CSCC

Jason M. Broderick @jasoncology
Published: Friday, Sep 28, 2018

The FDA has approved the PD-1 inhibitor cemiplimab (Libtayo) for the treatment of patients with metastatic cutaneous squamous cell carcinoma (CSCC) or patients with locally advanced CSCC who are not candidates for curative surgery or curative radiation.

At a median follow-up of 7.9 months, 28 of 59 patients had a response, including 4 (6.8%) complete responses and 24 (40.7%) partial responses. Among the responders, 57% had responses >6 months, and 82% had an ongoing response and continued to receive the PD-1 inhibitor. Responses were observed irrespective of prior systemic therapy.


The phase II trial included patients with either metastatic or locally advanced CSCC. The data presented at ASCO were only for the cohort of 59 patients with metastatic disease. These patients received cemiplimab intravenously at 3 mg/kg every 2 weeks. The median age of the 59 patients was 71 (range, 38-93), with 43 (73%) patients aged ≥65 years. 

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